Tests a special diet with anti-TNF drugs in adults with Crohn's disease
Tests a special exclusion diet added to anti-TNF drugs in adults with Crohn's disease.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease
Key facts
- Where
- Guangzhou, ChinaSee the site
Where in China
- Sixth afflicated of Sun-yat sen universityGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sixth Affiliated Hospital, Sun Yat-sen University
- Trial code
- NCT07344428
- Record updated
- 10 July 2026
- Original description
Crohn's disease (CD) is a chronic inflammatory bowel disease with high recurrence and surgical rates. Mucosal healing is a key therapeutic goal, yet current anti-TNF-α biologics achieve only about 30% mucosal healing. Dietary intervention, particularly the Crohn's Disease Exclusion Diet (CDED), shows promise in CD management. Preliminary data suggest that combining CDED with anti-TNF-α biologics may significantly improve mucosal healing rates (42.9% vs 25%). This single-center, prospective, randomized, controlled trial will enroll 185 adult CD patients with active disease (SES-CD ≥3), randomly assigned 1:1 to receive either anti-TNF-α biologics plus CDED or anti-TNF-α biologics alone. The primary endpoint is mucosal healing rate at week 14 (SES-CD=0). Secondary endpoints include clinical remission, endoscopic response, transmural healing, and adverse events. This study aims to provide high-quality evidence for the efficacy and safety of this combined approach in Chinese CD patients.Read full original descriptionShow less
Therapeutic Effect of Exclusion Diet Combined With Anti-TNF-α Biologics in Adult Patients With Crohn's Disease in China: A Single-center, Prospective, Randomized, Controlled Trial
Crohn's disease (CD) is a chronic inflammatory bowel disease with high recurrence and surgical rates. Mucosal healing is a key therapeutic goal, yet current anti-TNF-α biologics achieve only about 30% mucosal healing. Dietary intervention, particularly the Crohn's Disease Exclusion Diet (CDED), shows promise in CD management. Preliminary data suggest that combining CDED with anti-TNF-α biologics may significantly improve mucosal healing rates (42.9% vs 25%). This single-center, prospective, randomized, controlled trial will enroll 185 adult CD patients with active disease (SES-CD ≥3), randomly assigned 1:1 to receive either anti-TNF-α biologics plus CDED or anti-TNF-α biologics alone. The primary endpoint is mucosal healing rate at week 14 (SES-CD=0). Secondary endpoints include clinical remission, endoscopic response, transmural healing, and adverse events. This study aims to provide high-quality evidence for the efficacy and safety of this combined approach in Chinese CD patients.
Inclusion: Age ≥18 years; Diagnosis of Crohn's disease confirmed by endoscopy and histopathology, with active disease (CDAI ≥150); Indicated for anti-TNF-α biologic therapy (infliximab or adalimumab) and naïve to these agents; Willing and able to provide written informed consent; Able to understand and comply with study requirements, including dietary intervention and scheduled follow-up.
Exclusion: Recent use (within 3 months) of other immunosuppressants (e.g., azathioprine, methotrexate) or high-dose corticosteroids (e.g., prednisone >20 mg/day); Concurrent participation in another clinical trial, or any condition that makes the patient unsuitable in the investigator's opinion; Presence of severe complications requiring surgical intervention (e.g., intestinal obstruction, intra-abdominal abscess, intestinal fistula); Active tuberculosis, active hepatitis B, HIV infection, or other severe opportunistic infections; Current or history of malignancy, except non-melanoma skin cancer; Severe food allergies, celiac disease, severe malnutrition (BMI <18.5 kg/m²), or inability to adhere to CDED; Severe cardiac, hepatic, or renal insufficiency (e.g., Child-Pugh class C, or eGFR <30 mL/min/1.73 m²); Pregnant or breastfeeding, or planning pregnancy during the study period.